# Takeda Pharmaceutical Company Limited – FDA 483, May 24, 2023

Source: https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/ac78eb79-a4fa-40e6-a809-4bde4790ca58

> FDA 483 for Takeda Pharmaceutical Company Limited on May 24, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2023-05-24
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Takeda Pharmaceutical Company Limited in Hikari, Japan, was cited for multiple deficiencies during an FDA inspection related to sterile drug product manufacturing. The observations primarily concern inadequate controls for preventing microbiological contamination, deficient environmental monitoring, and incomplete quality control procedures. The firm also failed to properly investigate discrepancies, maintain equipment, and update disinfectant efficacy studies.

## Related Documents

- [483 - 2023-11-06](https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/9830bf69-579a-4bc0-bf7c-8ad2b78a6e53) — date: November 6, 2023
- [483 - 2023-11-01](https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/1896dda4-c7e8-4da9-b91a-daba1da128bc) — date: November 1, 2023
- [483 - 2021-07-19](https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/d7328c43-e92f-449d-bccf-293394b50bdc) — date: July 19, 2021
- [EIR - 2019-11-26](https://www.keypedia.com/records/eir/takeda-pharmaceutical-company-limited/921c7f71-9c2e-46ae-90ad-9ea313e0e463) — date: November 26, 2019
- [483 - 2019-11-26](https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/58fc4bcb-d16e-4868-88eb-9a01737e1cc2) — date: November 26, 2019

## Related Officers

- [Vidya B. Pai](https://www.keypedia.com/people/vidya-b-pai/bbe3989c-b7b0-40a0-ae0b-a35c81cdd179)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)

Company: https://www.keypedia.com/companies/takeda-pharmaceutical-company-limited/0f6bd1ca-94a2-41f0-a8dd-1af20069e6cf

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321